EP3353480A4 - Appareil et procédé de mise au point de protocoles de lyophilisation utilisant de petits lots de produit - Google Patents

Appareil et procédé de mise au point de protocoles de lyophilisation utilisant de petits lots de produit Download PDF

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Publication number
EP3353480A4
EP3353480A4 EP16849366.6A EP16849366A EP3353480A4 EP 3353480 A4 EP3353480 A4 EP 3353480A4 EP 16849366 A EP16849366 A EP 16849366A EP 3353480 A4 EP3353480 A4 EP 3353480A4
Authority
EP
European Patent Office
Prior art keywords
product
freeze drying
small batches
drying protocols
developing
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP16849366.6A
Other languages
German (de)
English (en)
Other versions
EP3353480A1 (fr
Inventor
T.N. Thompson
Qiming Wang
Richard Martino
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Millrock Technology Inc
Original Assignee
Millrock Technology Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Millrock Technology Inc filed Critical Millrock Technology Inc
Publication of EP3353480A1 publication Critical patent/EP3353480A1/fr
Publication of EP3353480A4 publication Critical patent/EP3353480A4/fr
Pending legal-status Critical Current

Links

Classifications

    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26—DRYING
    • F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B5/00—Drying solid materials or objects by processes not involving the application of heat
    • F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
    • F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26—DRYING
    • F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B21/00—Arrangements or duct systems, e.g. in combination with pallet boxes, for supplying and controlling air or gases for drying solid materials or objects
    • F26B21/06—Controlling, e.g. regulating, parameters of gas supply
    • F26B21/10—Temperature; Pressure
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26—DRYING
    • F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B3/00—Drying solid materials or objects by processes involving the application of heat
    • F26B3/18—Drying solid materials or objects by processes involving the application of heat by conduction, i.e. the heat is conveyed from the heat source, e.g. gas flame, to the materials or objects to be dried by direct contact
    • F26B3/20—Drying solid materials or objects by processes involving the application of heat by conduction, i.e. the heat is conveyed from the heat source, e.g. gas flame, to the materials or objects to be dried by direct contact the heat source being a heated surface, e.g. a moving belt or conveyor
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26—DRYING
    • F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B9/00—Machines or apparatus for drying solid materials or objects at rest or with only local agitation; Domestic airing cupboards
    • F26B9/06—Machines or apparatus for drying solid materials or objects at rest or with only local agitation; Domestic airing cupboards in stationary drums or chambers
    • F26B9/066—Machines or apparatus for drying solid materials or objects at rest or with only local agitation; Domestic airing cupboards in stationary drums or chambers the products to be dried being disposed on one or more containers, which may have at least partly gas-previous walls, e.g. trays or shelves in a stack

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • General Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Molecular Biology (AREA)
  • Microbiology (AREA)
  • Drying Of Solid Materials (AREA)
EP16849366.6A 2015-09-22 2016-09-15 Appareil et procédé de mise au point de protocoles de lyophilisation utilisant de petits lots de produit Pending EP3353480A4 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201562222136P 2015-09-22 2015-09-22
US201662279564P 2016-01-15 2016-01-15
US15/228,100 US10605527B2 (en) 2015-09-22 2016-08-04 Apparatus and method for developing freeze drying protocols using small batches of product
PCT/US2016/051824 WO2017053160A1 (fr) 2015-09-22 2016-09-15 Appareil et procédé de mise au point de protocoles de lyophilisation utilisant de petits lots de produit

Publications (2)

Publication Number Publication Date
EP3353480A1 EP3353480A1 (fr) 2018-08-01
EP3353480A4 true EP3353480A4 (fr) 2019-07-03

Family

ID=58276971

Family Applications (1)

Application Number Title Priority Date Filing Date
EP16849366.6A Pending EP3353480A4 (fr) 2015-09-22 2016-09-15 Appareil et procédé de mise au point de protocoles de lyophilisation utilisant de petits lots de produit

Country Status (5)

Country Link
US (3) US10605527B2 (fr)
EP (1) EP3353480A4 (fr)
JP (2) JP7144319B2 (fr)
CN (1) CN108139151B (fr)
WO (1) WO2017053160A1 (fr)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10605527B2 (en) 2015-09-22 2020-03-31 Millrock Technology, Inc. Apparatus and method for developing freeze drying protocols using small batches of product
CN108896433B (zh) * 2018-09-05 2020-09-11 福建省闽东力捷迅药业有限公司 一种验证冷冻干燥机板层热分布均匀性和升华效率的方法
JP2022525398A (ja) * 2019-03-14 2022-05-13 テルモ ビーシーティー バイオテクノロジーズ，エルエルシー 凍結乾燥容器用充填治具、システム及び使用方法
US11732964B2 (en) 2020-04-15 2023-08-22 Navinta Iii Inc Lyophilization promoting element
EP4348141A1 (fr) * 2021-06-01 2024-04-10 Amgen Inc. Système de lyophilisation
WO2024003424A1 (fr) * 2022-06-28 2024-01-04 Compliance Consulting And Engineering Services, S.L. Système de commande du procédé de lyophilisation dans un lyophiliseur avec système de château de plaques et procédé pour la génération d'un espace de conception

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JPH02169984A (ja) * 1988-12-23 1990-06-29 Kyowa Shinku Gijutsu Kk 凍結乾燥方法と凍結乾燥装置の乾燥庫
US5398426A (en) * 1993-12-29 1995-03-21 Societe' De Gestion Et De Diffusion North America, Inc. Process and apparatus for desiccation
US20040060191A1 (en) * 2002-04-23 2004-04-01 Bayer Aktiengesellschaft Freeze-drying apparatus
US20040250441A1 (en) * 2001-07-06 2004-12-16 Peter Haseley Chamber for a freeze-drying device
JP2014214992A (ja) * 2013-04-26 2014-11-17 共和真空技術株式会社 凍結乾燥用の棚及びその棚を用いた凍結乾燥装置

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US3961424A (en) 1975-08-28 1976-06-08 General Foods Corporation Process for freezing coffee extract prior to lyophilization
FR2508993A1 (fr) 1981-07-01 1983-01-07 Usifroid Installation de lyophilisation a double serie d'etageres
US4780964A (en) 1987-11-30 1988-11-01 Fts Systems, Inc. Process and device for determining the end of a primary stage of freeze drying
JPH0672742B2 (ja) * 1989-05-12 1994-09-14 共和真空技術株式会社 凍結真空乾燥装置および凍結真空乾燥方法
DE4033781C1 (fr) * 1990-10-24 1992-01-30 Mercedes-Benz Aktiengesellschaft, 7000 Stuttgart, De
US5367786A (en) 1990-11-06 1994-11-29 Jennings; Thomas A. Method and apparatus for monitoring the processing of a material
FR2685065B1 (fr) 1991-12-12 1994-03-04 Guy Beurel Procede de regulation de lyophilisation.
BR9510380A (pt) 1995-02-14 1998-06-02 George Wilhelm Oetjen Processo para a determinação da umidade residual durante a ressecagem em um processo de liofilização
JPH09113133A (ja) * 1995-10-16 1997-05-02 Kyowa Shinku Gijutsu Kk 凍結乾燥機の凍結乾燥工程における乾燥対象物温度の監視方法と凍結乾燥機
US5689895A (en) 1996-10-31 1997-11-25 S.P. Industries, Inc., The Virtis Division Probe positioning device for a flask freeze drying
DE19719398A1 (de) 1997-05-07 1998-11-12 Amsco Finn Aqua Gmbh Verfahren zur Steuerung eines Gefriertrocknungsprozesses
US6220048B1 (en) 1998-09-21 2001-04-24 Praxair Technology, Inc. Freeze drying with reduced cryogen consumption
US6643950B2 (en) 2000-12-06 2003-11-11 Eisai Co., Ltd. System and method for measuring freeze dried cake resistance
US6971187B1 (en) 2002-07-18 2005-12-06 University Of Connecticut Automated process control using manometric temperature measurement
CN100334894C (zh) 2002-11-04 2007-08-29 捷讯研究有限公司 维持无线数据连接的方法与系统
WO2004047753A2 (fr) 2002-11-21 2004-06-10 Transform Pharmaceuticals, Inc. Systeme de platine de microscope pour lyophilisation et methode d'utilisation de ce systeme
DK1794524T3 (da) * 2004-07-23 2012-04-16 Bayer Technology Services Gmbh Fremgangsmåde til frysning, tørring, lagring, analysering og fyldning (SFD-SAF-fremgangsmåde) (fremgangsmåde til frysetørring af piller til parenterale biologiske lægemidler)
WO2007079292A2 (fr) 2005-12-29 2007-07-12 Boehringer Ingelheim Vetmedica, Inc. Procede et appareil de surveillance precise de la temperature dans des chambres de lyophilisation
US8793895B2 (en) 2006-02-10 2014-08-05 Praxair Technology, Inc. Lyophilization system and method
CN100376880C (zh) * 2006-03-02 2008-03-26 浙江大学 验证冻干机搁板温度分布均匀性的测温垫系统
ITTO20060270A1 (it) 2006-04-11 2007-10-12 Torino Politecnico Ottimazione e controllo del processo di liofilizzazione di prodotti farmaceutici
EP1870649A1 (fr) 2006-06-20 2007-12-26 Octapharma AG Lyophilisation visant à obtenir une humidité résiduelle déterminée par énergie de désorption aux niveaux limités
US8015841B2 (en) * 2006-09-08 2011-09-13 Praxair Technology, Inc. Cryogenic refrigeration system for lyophilization
EP1903291A1 (fr) * 2006-09-19 2008-03-26 Ima-Telstar S.L. Procédé et système pour commander un procédé de lyophilisation
RU2009111140A (ru) 2006-10-03 2010-11-10 Вайет (Us) Устройства и способы лиофилизации
US8240065B2 (en) 2007-02-05 2012-08-14 Praxair Technology, Inc. Freeze-dryer and method of controlling the same
CA2697699C (fr) * 2007-08-28 2016-12-13 Arzneimittel Gmbh Apotheker Vetter & Co. Ravensburg Dispositif de regulation thermique de produits a lyophiliser
TWI436789B (zh) 2008-01-21 2014-05-11 Intervet Int Bv 含有藥學化合物的顆粒之冷凍乾燥方法及含有此顆粒的藥學包
JP2010144966A (ja) 2008-12-17 2010-07-01 Kyowa Shinku Gijutsu Kk 凍結乾燥装置
EP2202472A1 (fr) 2008-12-29 2010-06-30 Ludwig-Maximilians-Universität München Dispositif de surveillance de lyophilisateur
US20110179667A1 (en) * 2009-09-17 2011-07-28 Lee Ron C Freeze drying system
CN201653078U (zh) * 2009-12-31 2010-11-24 梅州永利机械设备实业有限公司 全自动真空冷冻干燥设备
FR2955927B1 (fr) 2010-02-01 2012-04-06 Alcatel Lucent Dispositif et procede de pilotage d'une operation de deshydratation durant un traitement de lyophilisation
US8689460B2 (en) * 2010-09-28 2014-04-08 Baxter International Inc. Optimization of nucleation and crystallization for lyophilization using gap freezing
US8966782B2 (en) 2010-09-28 2015-03-03 Baxter International Inc. Optimization of nucleation and crystallization for lyophilization using gap freezing
US8434240B2 (en) * 2011-01-31 2013-05-07 Millrock Technology, Inc. Freeze drying method
WO2012108470A1 (fr) 2011-02-08 2012-08-16 共和真空技術株式会社 Procédé et dispositif de calcul de la température d'une interface de sublimation, de la température d'une partie inférieure et de la vitesse de sublimation d'une matière à dessécher dans un dispositif de lyophilisation
US8839528B2 (en) 2011-04-29 2014-09-23 Millrock Technology, Inc. Controlled nucleation during freezing step of freeze drying cycle using pressure differential ice fog distribution
US8875413B2 (en) 2012-08-13 2014-11-04 Millrock Technology, Inc. Controlled nucleation during freezing step of freeze drying cycle using pressure differential ice crystals distribution from condensed frost
US9435586B2 (en) 2012-08-13 2016-09-06 Millrock Technology, Inc. Controlled nucleation during freezing step of freeze drying cycle using pressure differential ice crystals distribution from condensed frost
US9170053B2 (en) * 2013-03-29 2015-10-27 Tokitae Llc Temperature-controlled portable cooling units
US9121637B2 (en) * 2013-06-25 2015-09-01 Millrock Technology Inc. Using surface heat flux measurement to monitor and control a freeze drying process
US9470453B2 (en) 2013-08-06 2016-10-18 Millrock Technology, Inc. Controlled nucleation during freezing step of freeze drying cycle using pressure differential water vapor CO2 ice crystals
CN203758626U (zh) 2013-12-27 2014-08-06 楚天科技股份有限公司 用于自动进料冻干机的温度监控装置
US10605527B2 (en) 2015-09-22 2020-03-31 Millrock Technology, Inc. Apparatus and method for developing freeze drying protocols using small batches of product

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH02169984A (ja) * 1988-12-23 1990-06-29 Kyowa Shinku Gijutsu Kk 凍結乾燥方法と凍結乾燥装置の乾燥庫
US5398426A (en) * 1993-12-29 1995-03-21 Societe' De Gestion Et De Diffusion North America, Inc. Process and apparatus for desiccation
US20040250441A1 (en) * 2001-07-06 2004-12-16 Peter Haseley Chamber for a freeze-drying device
US20040060191A1 (en) * 2002-04-23 2004-04-01 Bayer Aktiengesellschaft Freeze-drying apparatus
JP2014214992A (ja) * 2013-04-26 2014-11-17 共和真空技術株式会社 凍結乾燥用の棚及びその棚を用いた凍結乾燥装置

Also Published As

Publication number Publication date
US20170082361A1 (en) 2017-03-23
US11885564B2 (en) 2024-01-30
JP2018530731A (ja) 2018-10-18
JP7144319B2 (ja) 2022-09-29
US10605527B2 (en) 2020-03-31
CN108139151A (zh) 2018-06-08
WO2017053160A1 (fr) 2017-03-30
JP7295931B2 (ja) 2023-06-21
EP3353480A1 (fr) 2018-08-01
US11486640B2 (en) 2022-11-01
CN108139151B (zh) 2020-09-01
US20190285342A1 (en) 2019-09-19
JP2022033989A (ja) 2022-03-02
US20200149815A1 (en) 2020-05-14

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